Kornimate/medical-research-clean huggingface dataset:
functional inspiratory muscle training in chronic kidney disease

Conditions: Chronic Kidney Diseases

Summary: effects of functional inspiratory muscle training by telerehabilitation on respiratory and peripheral functions, functional capacity, diaphragm thickness and mobility, posture, quality of life, cognitive function, fatigue, physical activity, endothelial function and aortic stiffness in patients with chronic kidney disease will be investigated.


Eligibility criteria:
inclusion criteria: * patients with chronic kidney disease not receiving dialysis * access to the online program * volunteering to participate in the research exclusion criteria: * having a musculoskeletal problem * having decompensated diabetes * having uncontrolled hypertension

Keywords: respiratory muscle
cost-effectiveness of in-shoe pressure measurement for therapeutic shoes

Conditions: Diabetes Mellitus; Polyneuropathies

Summary: the purpose of this study is determine whether the use of plantar pressure measurements in the production of customized therapeutic footwear for patients with diabetes and a history of foot ulceration results in lower production costs and more pressure relief, compared to the standard production. a secondary objective is to explore if a difference in durability can be observed in pressure reduction and development of (pre-) ulcerative lesions between the shoes produced with and without plantar pressure measurements.

for each patient two pairs of shoes will be produced by two shoemakers, one using plantar pressure measurements and one according current standard production procedures. the patient will wear one of these two pairs of shoes during a period of 3 months.

Eligibility criteria:
inclusion criteria: * diabetes * neuropathy * prescription of therapeutic footwear * diabetic foot ulcer in the last 5 years * receiving regular preventive foot care * written informed consent exclusion criteria: * peripheral arterial disease * not motivated to wear therapeutic footwear * active foot ulcer * recent vascular intervention * severe mobility impairment * amputation more proximal than toes, except a single ray amputation is allowed. * severe visual impairment * active cancer * severe cardiac/ pulmonary failure * severe oedema * chronic drug abuse * severe psychiatric illness * hospital admission at the time of inclusion * any condition that may interfere with follow-up visits.
lurasidone - a 24-week extension study of patients with bipolar i depression

Conditions: Bipolar Depression

Summary: this clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar i depression


Eligibility criteria:
inclusion criteria: * subject is judged by the investigator to be suitable for participation in a 24-week clinical trial involving open-label lurasidone treatment * subject has completed the 6-week treatment period and all required assessments on the final study visit (day 42, visit 8) of either study d1050235, nct#00868452 or study d1050236, nct#008668699. exclusion criteria: * imminent risk of suicide, injury to self or to others, or damage to property * subject has evidence of severe movement disorders. * subject tests positive for drugs of abuse (at visit 8 in study d1050235, nct#00868452 or d1050236, nct#008688699).

Keywords: bipolar depression lurasidone latuda
application of epirubicin within a neo-/adjuvant chemotherapy in patients with primary breast cancer

Conditions: Breast Neoplasm

Summary: evaluation of efficacy of treatment with epirubicin (5 years follow-up). evaluation of frequency of dose reduction. evaluation of frequency of neoadjuvant treatment with e(120mg) / c(600mg). evaluation of unexpected and serious adverse events. (e=epirubicin; c =cyclophosphamide)

postmarketing surveillance study. non-probability sample

Eligibility criteria:
inclusion criteria: * pre- and postmenopausal female patients with histologically confirmed primary breast cancer exclusion criteria: * metastatic breast cancer, locally advanced or recurrent breast cancer, previous cancer history

Keywords: breast cancer neoadjuvant treatment chemotherapy adjuvant epirubicin
weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure

Conditions: Inadequate or Impaired Breathing Pattern or Ventilation

Summary: the purpose of this study is to determine whether helmet is effective as device for noninvasive positive pressure ventilation in the weaning from mechanical ventilation.

the clinical efficacy of noninvasive positive pressure ventilation (nppv) has been demonstrated. interest has emerged in using nppv to facilitate earlier removal of an endotracheal tube and decrease complications associated with prolonged intubation. studies assessing nppv in weaning are not enough and generally are performed with face masks as device for nppv. this study assesses the efficacy of helmet as device for nppv during weaning from mechanical ventilation in an icu and compares this procedure with invasive mechanical complication (imv) by analyzing respiratory parameters, clinical course and complications.

Eligibility criteria:
inclusion criteria: * endotracheal mechanical ventilation for 48 hours or more for acute respiratory failure, * patient ready to be weaned (steady respiratory and hemodynamic conditions for 24 hours), * spontaneous breathing trial failure * written informed consent obtained (patient or family) exclusion criteria: * respiratory and hemodynamic instability * initial difficult intubation * bronchial hypersecretion at the weaning time * non cooperant patient * recent history of upper gastro-intestinal surgery * recent history of myocardial infarction

Keywords: mechanical ventilation weaning noninvasive ventilation acute respiratory failure helmet
adaptresponse clinical trial

Conditions: Heart Failure With Left Bundle Branch Block

Summary: the purpose of this clinical study is to test the hypothesis that market released cardiac resynchronization therapy (crt) devices which contain the adaptivcrt® (acrt) algorithm have a superior outcome compared to standard crt devices in crt indicated patients with normal atrio-ventricular (av) conduction and left bundle branch block (lbbb).


Eligibility criteria:
inclusion criteria: * subject is willing to sign and date the study patient informed consent form. * subject is indicated for a crt device according to local guidelines. * sinus rhythm at time of enrollment * complete left bundle branch block (lbbb) as documented on an ecg (within 30 days prior to enrollment). strauss criteria used for lbbb. * intrinsic, normal av conduction as documented on an ecg by a pr interval less than or equal to 200ms (within 30 days prior to enrollment). * left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment). * nyha class ii, iii or iv (documented within 30 days prior to enrollment) despite optimal medical therapy. optimal medical therapy is defined as maximal tolerated dose of beta-blockers and a therapeutic dose of ace-i, arb or aldosterone antagonist. exclusion criteria: * subject is less than 18 years of age (or has not reached minimum age per local law). * subject is not expected to remain available for at least 2 years of follow-up visits. * subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted * subject is, or previously has been, receiving cardiac resynchronization therapy. * subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the medtronic study manager. * subject has unstable angina, or experienced an acute myocardial infarction (mi) or received coronary artery revascularization (cabg) or coronary angioplasty (ptca) within 30 days prior to enrollment. * subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study. * subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded). * subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study. * subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant). * subject meets any exclusion criteria required by local law.

Keywords: adaptivcrt acrt
management of abnormally fertilized zygotes? invitro correction of 3pn

Conditions: Infertility

Summary: in this newly developed protocol, and idea, is to manage those abnormally developed zygotes from different art procedures. the investigators developed the plan and requirements needed to select the target extra nucleus or pronuclei to be extruded from fertilized egg in order to maintain developing healthy normal embryo.

as approved by dyban and baranov et al, about 15-18% of abortions caused by triploidy fertilization. one of sources for maternally triploidy is failure in the first meiotic division (jacobs et al., 1978). one of digynic triploidy is developed by fertilized giant oocyte (dyban and baranov, 1987) {nuclear but no cytoplasmic division in an oogonium or cytoplasmic fusion of two oogonia (austin, 1960)}. giant oocyte characterized with bigger diameter and will distinguished polar bodies at metaphase ii. b. rosenbusch et. al. 2002, cytogenetic study showed that extra haploid maternal copy associated with mii (46,xx/ 2n ) giant oocytes as well as triploidy with fertilized giant oocytes (3n with 69,xxx or 69,xxy). first mitotic division plane with polar axes studies by scott, 2001 , shows that pn developed closer to 2nd polar body is the maternal origin pn. giant oocytes were collected from different ivf cycles, to be injected with normal sperm using intracytoplasmic sperm injection (icsi). 18 hours post icsi arranged for fertilization evaluation and pn removal for fertilized oocyte before syngamy starts. video attached shows process of zygote manipulation by the way avoiding the division axis and focusing the extra maternal pn to be aspirated. pronuclear transfer in human embryos for mitochondrial dna correction started the methodology of pronuclear manipulation, for that possibility of utilizing of 3pns developed embryos research tools can be started. we arranged to study available received giant oocytes during ivf cycles. accordingly we arranged for pronuclear removal followed by fish evaluation in order to targeting normal males embryos that insure proper extra maternal pronucleus removal. successful trials of maternal pn removal for giant oocyte collected from different cases summarized in table 1. all blastocyst developed arranged for fish, so all embryos were utilized for cytogenetic evaluation. recommendations: further evaluations using strs (short tandem repeat ) should be used for maternal-paternal genome differentiation. ngs study is under evaluation for developed embryos for full ccs reporting and more genetic integrity. epigenetic evaluation study recommended for triploidy corrected embryos for genetic expressions and early embryo developments as well as differentiation between paternal and maternal genomic activity.

Eligibility criteria:
inclusion criteria: * giant oocytes * 3 pns developed embryos at day 1 post icsi. exclusion criteria: * patient refused to involving their abnormal oocytes at our study.

Keywords: abnormal zygote fertilization 3pns correction giant oocyte management triploidy fertilization maternal nucleus removal
high intensity interval training in geriatrics

Conditions: Muscle Weakness; Gait, Unsteady

Summary: this is a pilot study for evaluating the feasibility of using high intensity interval training in geriatric hospitalized patients compared to the standard current rehabilitation practice.

high intensity interval training (hiit) has shown a superior effectiveness and efficiency when compared to moderate intensity continuous training (mict) in several types of patients and in healthy subjects. there are no data on hiit in a general geriatric population. this study is a pilot study evaluating the feasibility of using hiit in geriatric hospitalized patients compared to the standard current rehabilitation practice without hiit. it is our desire to perform a larger randomized comparative trial between hiit and mict if the pilot study proves its feasibility.

Eligibility criteria:
inclusion criteria: * patients aged 65 years and older hospitalized for rehabilitation after an acute medical condition * expected duration of the rehabilitation ≥ 2 weeks * ability to follow instructions to perform a timed up and go test * ability to perform exercises * willing to participate in 4 sessions of hiit per week for 2 weeks exclusion criteria: * any acute condition with tachycardia, hypotension or fever. * abnormal cycle ergometer stress test with * significant ecg modification * decrease of more than 20 mmhg of the blood pressure with exercise * angina * st depression at a workload \<6 mets * inability to reach an intensity of 15/20 in the borg's scale of perceived exertion * any unresolved acute medical or surgical condition of the following kind: * acute heart failure * acute coronary syndrome \< 1 month * strole \< 1 month * active pericarditis / myocarditis / endocarditis * thromboembolic disease with \< 2 weeks of anticoagulation * acute infection requiring intravenous treatment * ongoing intravenous perfusion * surgery \< 2 months * recent bone fracture * previous episode of primary cardiac arrest (ie, cardiac arrest that did not occur in the presence of an acute myocardial infarction or during a cardiac procedure). * severe heart failure (nyha iii and iv) * severe stenotic or regurgitant valvular disease * uncontrolled hypertension at rest (sbp≥160mmhg, dbp≥100mmhg) * uncontrolled dysrhythmia * non-sustained ventricular tachycardia with exercise * implanted defibrillator * obstructive cardiomyopathy * resting hr \> 100/min * severe peripheral artery disease * severe copd (vems \< 50%) * exercise-induced asthma * oxygen dependency * muscular-skeletal anomaly that may limit exercise participation * delirium * inability to follow instructions * inability to consent
evaluating effects of a left bundle branch block

Conditions: Mechanical Dyssynchrony; Heart Failure; Bundle-Branch Block

Summary: a left bundle branch block (lbbb) is related to abnormal cardiac conduction and mechanical asynchrony and is associated with hypertension and coronary artery disease. improved evaluation of left ventricular (lv) mechanical asynchrony is needed, because of the increasing number of patients with a lbbb and heart failure. a variety of patterns of mechanical activation can be observed in lbbb patients. novel imaging modalities such as tissue doppler imaging, real-time 3d echocardiography and cardiovascular magnetic resonance imaging provide information about regional and global lv function in healthy subjects, patients without a lbbb with heart failure, patients with a lbbb without heart failure, and patients with a lbbb with heart failure. the investigators want to evaluate the different patient groups with the novel imaging modalities and they want to compare the novel imaging modalities with each other. the investigators hypothesized that, between the groups, differences concerning regional and global lv function are measurable. each novel imaging technique has its own advantages and limitations but are comparable in measuring regional and global lv function.

within a time period of 3 years we evaluate different groups of patients and measure regional and global cardiac function. therefore, we developed an echocardiography screening-protocol in which we use conventional 2d echocardiography and conventional doppler echocardiography, extended with tissue doppler imaging and real-time 3d echo acquisitions. in a limited group of patients we perform a specially designed cardiovascular magnetic resonance imaging protocol which uses artificially induced grid-lines to evaluate regional and global cardiac function. patients are referred to our hospital because of evaluation of their lbbb and or heart failure. we ask them if they would like to undergo the echocardiography and the cardiovascular magnetic resonance imaging. after a year we want to repeat the measurements in a small group of the patients to re-evaluate regional and global cardiac function. all patients should have a sinus rhythm and adequate acoustic windows. patients should not have contraindications for cardiovascular magnetic resonance imaging.

Eligibility criteria:
inclusion criteria: * aged 18-85 years * left bundle branch block with or without heart failure * narrow qrs duration with or without heart failure exclusion criteria: * no informed consent * no sinus rhythm * poor acoustic window * for cardiovascular magnetic resonance imaging part: * claustrophobia * devices

Keywords: left bundle branch block regional cardiac function global cardiac function mechanical asynchrony echocardiography 2d echocardiography tissue doppler imaging real-time 3d echocardiography cardiovascular magnetic resonance imaging-tagging
evarrest™ fibrin sealant patch post-market study

Conditions: Hemorrhage; Soft Tissue Bleeding

Summary: the objective of this study is to evaluate the clinical utility of evarrest™ fibrin sealant patch (fibrin pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal (stomach area), retroperitoneal (hip and stomach area), pelvic (hip area) and non-cardiac thoracic (chest area) surgery.

this is a randomized, controlled single-center study observing the clinical utility of evarrest™ against standard of care (soc) in controlling soft tissue bleeding. standard of care will be manual compression (mc) with or without a topical absorbable hemostat (tah) or any other adjunctive hemostasis technique that is deemed by the surgeon to be his/her standard of care. all subjects will be followed post-operatively through discharge and at 30 (+/-14) days. approximately 150 qualified subjects undergoing intra-abdominal, retroperitoneal, pelvic and non-cardiac thoracic surgery requiring adjunctive support for hemostasis for soft tissue bleeding will be enrolled in the study. subjects will be randomized on a 1:1 basis, evarrest™ vs. soc.

Eligibility criteria:
inclusion criteria: * subjects ≥18 years of age, requiring an elective or urgent, open intra-abdominal, retroperitoneal, pelvic or non-cardiac thoracic surgical procedures; * subjects or legally authorized representative must be willing to participate in the study and provide written informed consent. * presence of an appropriate target bleeding site as identified intra-operatively by the surgeon; exclusion criteria: * subjects with known intolerance to blood products or to one of the components of evarrest™ or unwilling to receive blood products; * female subjects who are pregnant or nursing. * tbs is from a large defect in an artery or vein where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of evarrest™ to blood flow and/or pressure during absorption of the product; * tbs with major arterial bleeding requiring suture or mechanical ligation; * tbs within a contaminated or infected area of the body; * bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine; * subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;

Keywords: hemostasis
a phase iib study to investigate the efficacy and tolerability of lower doses cinaciguat (25 µg/h, 10 µg/h) given intravenously to patients with acute decompensated chronic congestive heart failure (adhf)

Conditions: Acute Heart Failure

Summary: a placebo controlled, double-blind and randomized study to assess different doses of a new drug (bay58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.


Eligibility criteria:
inclusion criteria: * male and non-pregnant, non-lactating female subjects, age \>/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy * subjects must have the clinical diagnosis of congestive heart failure (chf) made at least three months prior to enrollment * subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study: * dyspnea and * clinical evidence of volume overload exclusion criteria: * acute de-novo heart failure * acute myocardial infarction and/or myocardial infarction within 30 days * valvular heart disease requiring surgical intervention during the course of the study * heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease * primary hypertrophic cardiomyopathy * acute inflammatory heart disease, eg, acute myocarditis * unstable angina requiring angiography

Keywords: heart failure